Cleared Traditional

K972423 - RUSCH TRACHEOFIX-SET

K972423 is the FDA 510(k) clearance for RUSCH TRACHEOFIX-SET by Rusch Intl.. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K972423 · Rusch Intl. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
231d
Days
Class 2
Risk

K972423 is an FDA 510(k) clearance for the RUSCH TRACHEOFIX-SET. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Rusch Intl. (Jeffrey, US). The FDA issued a Cleared decision on February 13, 1998 after a review of 231 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rusch Intl. devices

Submission Details

510(k) Number K972423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1997
Decision Date February 13, 1998
Days to Decision 231 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 140d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOH Tube Tracheostomy And Tube Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - JOH Tube Tracheostomy And Tube Cuff

All 57
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K972423.
RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
K023918 · Rusch Intl. · Mar 2003
THE PERCUQUICK SET FOR PERCUTANEOUS DILATION TRACHEOSTOMY
K011210 · Rusch Intl. · Aug 2001
RUSCH SINGLE USE CRYSTAL TRACHEOSTOMY TUBE SET
K972546 · Rusch Intl. · Apr 1998
RUSCH ULTRA TRACHEOFLEX FENESTRATED KIT CUFFED,UNCUFFED/ RUSCH TRACHEOFLEX TRACHEOSTOMY KIT UNCUFFED STERILE
K964056 · Rusch Intl. · Oct 1997
SHILEY EXTENDED LENGTH, DISPOSABLE CANNULA, TRACHEOSTOMY TUBE: CUFFED, DISTAL EXTENSION, CUFFED, PROXIMAL EXTENSION, CUF
K971267 · Mallinckrodt Medical · Sep 1997
PERCUTANEOUS DUAL CANNULA TRACHEOSTOMY TUBE WITH LOW PRESSURE/LOW PROFILE CUFF AND DISPOSABLE INNER CANNULA
K963732 · Mallinckrodt Medical · Jun 1997